MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

Catalog Number 121725500

Device Problem Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that upon the shrink wrap opened, it was noticed the product box was empty.There was no product inside.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Investigation summary: the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7002127
• MDR Text Key: 91084809
• Report Number: 1818910-2017-28106
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009900
• UDI-Public: 10603295009900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121725500
• Device Lot Number: D16011527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1